AuthorisedTherapeutic exploratory (Phase II)Interventional

HEMO trial - A randomized controlled trial of heparin bolus mobilization prior to peripheral hematopoietic cell collection from patients with lymphoma or myeloma

This study, called HEMO, is investigating a new way to collect more stem cells from people with blood cancers like lymphoma and myeloma. When these patients need a stem cell transplant, they first donate their own stem cells. This trial wants to see if giving a small dose of a blood-thinning medicine called heparin before collecting the stem cells can improve the number of cells collected. Researchers will compare this to giving a saline (salt water) solution, which is a standard approach. The main goal is to find out if heparin helps collect more stem cells on the first day. They're also checking how safe heparin is and if it helps patients reach their target number of stem cells more quickly. All adults, male or female, aged 18 and over, with lymphoma or myeloma, can be considered for this study.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Karolinska University Hospital

Enrolment target

100

Start

29 Apr 2024

Myelom Lymfom

What is this study about?

When someone has diseases like lymphoma or myeloma, they sometimes need a stem cell transplant. This process often involves collecting stem cells from their own blood. This can sometimes be challenging, and it might take multiple attempts to get enough cells for a successful transplant.

This research study, called HEMO, is looking into whether a common medicine, heparin, could make this process better. Heparin is a blood-thinning medicine. The study wants to see if giving a small amount of heparin before collecting stem cells can increase the number of cells gathered on the first day. The doctors are comparing this to giving a saline (salt water) solution, which acts as a comparison to see if heparin truly makes a difference.

The main aim is to see if heparin helps collect enough stem cells more efficiently. They will also be closely monitoring how safe it is to use heparin in this situation and if it helps patients reach their target number of stem cells with fewer collection sessions. This research is important because if successful, it could make the stem cell collection process smoother and more effective for patients with lymphoma and myeloma.

Key takeaways

This study explores a new way to collect more stem cells for lymphoma and myeloma patients.
It compares heparin (a blood thinner) with a salt solution to see if it improves cell collection.
The main goal is to collect more stem cells on the first day.
All adults (18+) with lymphoma or myeloma can be considered.
Safety, especially regarding bleeding, will be closely monitored.
Participation involves receiving either heparin or a salt solution and having your stem cells collected, with follow-up.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. Both men and women can take part. You must have been diagnosed with either lymphoma or myeloma, as the study is specifically looking at how we can improve stem cell collection for these conditions.

Your healthcare team will review your medical history and current health carefully to make sure this study is right for you. They will check all your health details to confirm you meet the study's specific requirements and that it's safe for you to participate.

The most important thing is that you have lymphoma or myeloma and are preparing for a stem cell collection procedure. Your doctor will discuss with you if this study fits your personal situation.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of lymphoma or myeloma?
Are you preparing to have your stem cells collected?
Are you able to provide your informed consent to participate?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be randomly assigned to receive either a small dose of heparin or a salt water solution before your stem cell collection. This is like flipping a coin, so neither you nor your doctor can choose which one you'll get.

During the study, you'll have regular blood tests to check your stem cell levels and overall health, especially to monitor any effects of the treatment. The main part of your participation will involve the stem cell collection process itself. Researchers will carefully measure how many stem cells are collected, especially on the first day, and if you meet the target number needed for your transplant.

Your medical records will be reviewed to keep track of any possible side effects, especially any bleeding complications, as heparin is a blood thinner. The total duration of your participation will focus on the period around your stem cell collection, with some follow-up to check your health afterwards.

Potential risks and benefits

Taking part in this study could potentially lead to collecting more stem cells on your first attempt, which might make your stem cell transplant process smoother. However, there's no guarantee this will happen. The main risk with heparin is that it's a blood thinner, which means there's a small chance of increased bleeding or bruising. Your healthcare team will monitor you very closely for any side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Sweden

Common questions

What are stem cells and why are they collected?

Stem cells are special cells that can develop into different types of blood cells. For people with certain blood cancers, collecting and transplanting their own healthy stem cells is a common treatment to help their body recover after intense cancer therapy.

What is heparin and why is it being used?

Heparin is a medicine that helps prevent blood clots. In this study, doctors want to see if it can help release more stem cells into your bloodstream, making them easier to collect.

Will I know if I'm getting heparin or the salt solution?

No, you won't know directly, and neither will your doctor for the main part of the study. This is called a 'blinded' study, which helps ensure the results are fair and unbiased.

What's the difference between lymphoma and myeloma?

Lymphoma is a cancer that starts in infection-fighting cells called lymphocytes, while myeloma is a cancer of plasma cells, another type of immune cell. Both are cancers of the blood system.

Who is paying for this study?

The information provided doesn't specify the funding source, but clinical trials are often funded by research grants, pharmaceutical companies, or government health organisations.